Associate Director, Regulatory Affairs, CMC

Job Description

Job Description

Reporting to the Chief Regulatory Officer, the Associate Director, Regulatory Affairs will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage gene therapy programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

Key Responsibilities include but are not limited to:

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management)
• Provide strategic input on manufacturing changes, comparability approaches, and control strategies
• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA)
• Lead preparation and authorship of CMC sections (Module 2.3, 3) for:
  • INDs / CTAs / Amendments
  • Briefing documents and health authority interactions
  • BLA/MAA submissions and supplements/variations
• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
• Oversee document quality, consistency, and compliance with global regulatory requirements
• Serve as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice)
• Prepare and review CMC briefing materials and response documents
• Support inspection readiness activities, including coordination with Quality and Manufacturing teams
• Provide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategies
• Ensure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapies

Qualifications:

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
• ~8–12+ years of regulatory affairs experience in biotech/pharma.
• Experience supporting biologics and/or gene/cell therapy products strongly preferred.
• Direct experience with IND/CTA submissions and global regulatory interactions required.
• Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies.
• Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)
• Proven ability to operate effectively in a small, fast-paced biotech environment
• Strong cross-functional leadership and influencing skills without direct authority
• Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $175,000 to $195,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.